Medline
- Product NDC
- 53329-259
- Requested package NDC
- 53329-259-64
- 11-digit product format
- 533290259
- Labeler code
- 53329
- Product ID
- 53329-259_50a03f0b-b618-c7ec-e063-6294a90a48e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-08
- Substance
- DIMETHICONE
- Active strength
- 66 mg/g
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Medline
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 66 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | e98d1d8c-c979-49de-9bd8-cd409efff6de | 2025-07-11 | Warnings | M016 |
| Neosporin Lip Health Overnight Renewal Therapy | PETROLATUM | Kenvue Brands LLC | 0da54fe1-c99f-4a2d-9ee5-2dc24005096c | 2025-07-10 | Warnings | M016 |
| COCOA BUTTER PETROLEUM jelly | PETROLATUM | Savvy Care & Cosmetics Pvt. Ltd. | 397d13f1-3b86-3c76-e063-6394a90a0f24 | 2025-07-09 | Warnings | M016 |
| Pipette Eczema | COLLOIDAL OATMEAL | Pipette LLC | 39829827-d801-f5a7-e063-6394a90a024c | 2025-07-09 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | Westminster Pharmaceuticals, LLC | 7e045b3a-f33b-4faa-ab9b-2baec6ff7924 | 2025-07-08 | Warnings | M016 |
| Desitin Multi-Purpose Healing | PETROLATUM | Kenvue Brands LLC | 30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab | 2025-07-07 | Warnings | M016 |
| Astringent Solution | ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE | First Nation Group | 065c895c-7d86-f1ed-e063-6394a90a3a52 | 2025-07-07 | Warnings | M016 |
| Creamy Petroleum | PETROLATUM | Savvy Care & Cosmetics Pvt Ltd | 3916daee-f8d2-e3f0-e063-6294a90a3883 | 2025-07-04 | Warnings | M016 |
| Exemax Cream | DIMETHICONE, ALLANTOIN | PureTek Corporation | 38e79055-df84-d314-e063-6394a90ac95f | 2025-07-01 | Warnings | M016 |
| Procure Dimethicone 5% | DIMETHICONE | Twin Med LLC | 38a7e4af-997d-549e-e063-6394a90a0bd6 | 2025-06-28 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53329-259-64 | 53329025964 | 142 g in 1 TUBE (53329-259-64) | 142 g | 2026-06-08 | No | No | Current |